American Academy of Pediatrics cautions against off-label use of COVID-19 vaccines in children under 12

Aug. 27, 2021

The Food and Drug Administration (FDA) finalized the full approval of the Pfizer-BioNTech COVID-19 vaccine for ages 16 and older. While questions may now arise about the administration of the vaccine off-label for children aged 11 and younger, who currently have no available vaccine, the American Academy of Pediatrics (AAP) has issued a release that strongly discourages that practice.

“The clinical trials for the COVID-19 vaccine in children ages 11 years old and younger are underway, and we need to see the data from those studies before we give this vaccine to younger children,” said AAP President Lee Savio Beers, MD, FAAP. “The dose may be different for younger ages. The AAP recommends against giving the vaccine to children under 12 until authorized by the FDA.”

While the FDA is considering full approval of the vaccine for ages 12 through 15, it is available under emergency use authorization for this age group now, and AAP strongly recommends all eligible adolescents be vaccinated as soon as possible. The data from clinical trials and experience with the vaccine over the past four months in these adolescents show that it is safe and very effective in this age group, said Dr. Beers.

The dose of the adult vaccine is much higher than the doses being tested in children younger than 12.

Yvonne Maldonado, MD, FAAP, chair of the AAP Committee on Infectious Diseases, urged physicians to wait until the clinical trials are complete in children to give the vaccine to those under 12.

“We do not want individual physicians to be calculating doses and dosing schedules one-by-one for younger children based on the experience with the vaccine in older patients,” Dr. Maldonado said. “We should do this based on all of the evidence for each age group, and for that we need the trials to be completed. I know parents are anxious to protect their children, but we want to make sure children have the full benefit of ongoing clinical trials.”

The AAP has called on FDA to work aggressively to authorize a vaccine for ages 11 and younger.

AAP release    

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